This invention concerns implants for human bodies, and particularly breast implants.
Implants are used to augment or re-shape body portions, or to replace or restore diseased or injured body parts or parts removed by surgery or trauma.
Of particular interest are breast prosthesis or implants which are used to augment, re-shape or replace human breast tissue.
Particularly, breast implants are used for placement between pectoral muscles and breast tissue. The implants can also be placed under pectoral muscles between pectoral muscles and the rib cage. Typically, implants are made of soft fluid impermeable rupture-preventing material such as silicone rubber. Layers of material may be used. The bags may be filled or inflated with fluid materials, usually a gel and more recently a or saline solution. A gel has been preferred because of its ability to match the weight and feel of tissue which the implants are designed to augment, supplant or replace, and because saline implants deflate rapidly if a leak develops.
At the time of this invention, concern with rupturing of the bag or leakage of the gel and its possible effect on long-range health has been expressed. It is believed that the concerns may be unfounded, since the preferred gel is stable and non-reactive with human biological fluids or tissue.
Simple replacement of the gel by saline solution is not satisfactory because saline does not have the weight and feel of the gel and saline solution flows more freely in the implant than the tissue which it replaces. In addition, even a minute crack or hole in the shell leads to rapid deflation of the implant, exposing the patient to the risks and expense of reparation.
Some of the biggest problems with the current saline implants are threefold: They deflate rapidly when the membrane is ruptured. They have a less natural feel than silicone implants. They are prone to compressive capsular formation.
The present invention is directed toward a solution of those problems.
Prior art implant devices may experience contracture, causing unwanted firmness of the implant which is intended to be soft and flexible. That is because scar tissue may tend to surround and may tend to compress the implant. Prior art implant devices have approached the problem by constructing outer surfaces of Teflon and roughening the outer surfaces to redirect scar tissue.
Prior art saline-filled implants are prone to rapid deflation. The present invention solves that problem by encapsulation of the saline.
Prior art saline-filled implants had an unnatural feel. The present design implant, by encapsulating the saline, gives a more viscous feel to the saline, matching the feel of normal breast tissue.
The present invention uses the non-smooth outer surfaces made of the prior art structure and composition to reduce the problem, and also uniquely tends to solve the problem by virtue of a changed inner structure.